Lipid filled formulations & Softgels
Ploërmel
NextPharma Ploërmel site is a centre of excellence for development of lipid-based formulations and manufacturing of Softgel for nutritional, and Softgel and Licaps® for OTC and Rx products.
The Ploërmel site can support customers who face bioavailability challenges through more than 20 years of experience in developing and manufacturing lipid-based dosage forms. The Ploërmel site consists of three fully segregated and dedicated buildings, one for nutritional products, another for pharmaceutical products and finally one dedicated to hormonal products. Each pharmaceutical facility can handle HPAPI and products sensitive to oxidation. The site was acquired from Lonza in 2021.
The following services are offered
Pharmaceutical Development
- Pharmaceutical formulation development
- Technical batches in a dedicated suite
- Scale-up (pilot-scale, production-scale)
- Technical transfer
- Validation
- Manufacturing of stability batches including registration and validation
- Galenic optimisation of existing formulation
Analytics
- Analytical development
- Validation
- Stability testing / ICH storage
- Quality control
- Market release
Commercial Manufacturing & Packaging Capacity
Nutritional Softgel | 1.8 billion capsules |
Pharmaceutical Softgel | 1.4 billion capsules |
Rx Hormonal Softgel | 0.7 billion capsules |
Pharmaceutical Licaps | 0.2 billion capsules |
Xcelodose | 1.5 million capsules |
Nutritional certificates | ISO22000, FOS (Friend of the Sea), Ecocert, Hallal |
Regulatory status | Anvisa (Brazil), US FDA, EMA, audited by Russian authorities |
Site contact information
Address
NextPharma
ZI de Camagnon
B.P. 320
56803 Ploërmel CEDEX
France
Phone
Fax
+33-297-721010